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The Latest Breaking News from FDA

Clovis Oncology's Rubraca Significantly Improves PFS In Ovarian Cancer Regardless Of Biomarker Status

Clovis Oncology Inc (NASDAQ:CLVS) announced positive topline data from the monotherapy arm of Phase 3 ATHENA-MONO trial of Rubraca (Rucaparib) as first-line maintenance treatment in ovarian cancer. Rubraca achieved the primary endpoint of significantly improved progression-free survival (PFS) compared with placebo (20.2 months vs. 9.2 months). The median PFS for the HRD-positive patient…

Benzinga

The Daily Biotech Pulse: Amylyx Announces Negative Adcom Vote, Clovis Jumps On Ovarian Cancer Data, Masimo Warns Of Q1 Shortfall

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

FDA Panel Votes Down On Amylyx's ALS Drug, Further Fading Its Hope For Regulatory Success

An advisory committee of the

Benzinga

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Pharmacy in hospital sealed for selling illegal drugs

CHANDIGARH: The food and drug administration department of the Haryana government on Wednesday raided and sealed a pharmacy counter inside a hospital in Faridabad for flouting norms .

The Times of India

FDA approves second shot for 50+

The authorization for another booster arrives just as BA.2 becomes the dominant strain in the U.S.

Salon

FDA panel narrowly sides against experimental ALS drug

Federal health advisers have narrowly ruled against an experimental drug for the debilitating illness known as Lou Gehrig’s disease

The Independent UK

FDA Rejects Akebia Therapeutics' Vadadustat For CKD-Associated Anemia

The FDA has issued a complete response letter (CRL) to Akebia Therapeutics Inc's (NASDAQ:AKBA) marketing application (NDA) for vadadustat for anemia due to chronic kidney disease (CKD). Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. The FDA issues a CRL to indicate that the review cycle for an application is complete…

Benzinga

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EMA Starts Review Of Sanofi-GlaxoSmithKline's COVID-19 Vaccine

The European Medicines Agency has started reviewing Sanofi SA (NASDAQ:SNY) and its partner GlaxoSmithKline Plc's (NYSE:GSK) application seeking conditional authorization for their COVID-19 vaccine. The vaccine candidate, Vidprevtyn, was already being evaluated under a rolling review by EMA. The drugmakers had earlier said that they would seek regulatory approval for their COVID-19 vaccine to be…

Benzinga

5 Healthcare Stocks Likely to Withstand a Recession

The healthcare industry has attracted massive investor interest since the onset of the COVID-19 pandemic and could remain in the limelight as COVID cases surge again and necessitate the need for more COVID shots. In addition, the healthcare sector is known to withstand recessions relatively well. So, with several analysts…

StockNews.com

Ketamine Wellness Centers Offering FDA Approved Esketamine Treatment For Major Depressive Disorder

Ketamine Wellness Centers subsidiary of Delic Holdings Corp (OTCQB: DELCF) (CSE:DELC) (FRA:6X0), has expanded its treatment options to include SPRAVATO nasal spray. The KWC clinics located in Houston, Las Vegas and Seattle will be offering this treatment option beginning April 1.

Benzinga

Adagio's COVID-19 Antibody Meets Primary Goals Across Pre & Post-Exposure Prophylaxis, Treatment

Adagio Therapeutics Inc's (NASDAQ:ADGI) Phase 2/3 trials evaluating 300 mg adintrevimab (ADG20) as pre-and-post-exposure prophylaxis (EVADE) and treatment (STAMP) for COVID-19 have met its primary endpoints. Following the emergence of the omicron variant, a pre-specified exploratory analysis in a subset of the pre-exposure cohort, adintrevimab exhibited a clinically meaningful reduction in cases…

Benzinga

FDA Says Yes To Testing Receptor Life's Dry Power Inhaled CBD To Treat Social Anxiety Disorder

The FDA accepted Receptor Life Sciences’ investigational new drug application for RLS103. RLS103, a dry powder inhaled CBD, which is a first-in-class drug/device combination product for the acute treatment of social anxiety disorder.

Benzinga

Does creatine make you stronger? How the supplement may boost athleticism

Creatine is one of the most popular sport nutrition supplements, but does it work the way people want it to? Inverse spoke to creatine users and sports performance experts to find out.

Inverse

Why BioNTech Shares Are Surging Today

BioNTech SE (NASDAQ:BNTX) reported Q4 FY21 revenues of €5.53 billion compared to €345.4 million a year ago, mainly due to high demand for the company's COVID-19 vaccine. BioNTech and its partner Pfizer Inc (NYSE:PFE) delivered approximately 2.6 billion doses of Comirnaty/BNT162b2 worldwide in 2021, including over 1 billion doses to low- and middle-income countries. As…

Benzinga

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The Conversation

COVID-19 vaccines for the youngest children may be inching closer to authorization – a pediatrician explains how they're being tested

For some parents of young children, the wait for COVID-19 vaccines has been long and agonizing.

Benzinga

The Daily Biotech Pulse: Roche's Lung Cancer Combo Therapy Flunks Late-Stage Study, Adagio Spikes On Positive COVID Antibody Data, Amylyx Awaits Adcom Verdict

Here's a roundup of top developments in the biotech space over the last 24 hours.

Benzinga

Omicron BA.2 Variant Represents More Than 50% COVID-19 Cases, Says CDC Estimates: WSJ

According to the Centers for Disease Control and Prevention estimates, the omicron BA.2 variant represents approximately 55% of new COVID-19 cases in the U.S., as signs suggest infections are edging higher again in parts of the Northeast.

Axios

America's choose-your-own-adventure vaccine approach could create confusion

The gap between the under-vaccinated and the ultra-vaccinated will continue to grow.

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news in one place.

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Benzinga

53 Biggest Movers From Yesterday

Gainers

Tribune News Service

Big Pharma is betting on bigger political ambitions from Sen. Tim Scott

Sen. Tim Scott, a rising star in the Republican Party with broad popularity in his home state of South Carolina, is getting showered with drug industry money before facing voters this fall.

Tribune News Service

FDA clears way for millions to get additional COVID-19 boosters

WASHINGTON — U.S. regulators cleared second booster doses of COVID-19 vaccine from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE for adults 50 and older, making millions more people eligible for the shots as concern grows about a potential new wave of infections.

Benzinga

CBD Is Expensive, How The Industry Can Re-Think Its Pricing For Consumers

By Alejandro Bergad The last two years haven’t been great for the CBD industry. The pandemic cratered in-store sales of CBD. Meanwhile, by choosing not to regulate CBD, the FDA left it in a legal gray area, limiting where it can be sold.

Benzinga

Here's Why Moderna Shares Are Rising

Moderna Inc (NASDAQ: MRNA) shares are trading higher by 4.67% at $181.16 after the company received FDA approval for Emergency Use Authorization for a second booster dose of its COVID-19 vaccine.

Los Angeles Times

Infectious omicron BA.2 now dominant in US, with coronavirus spring rise likely

LOS ANGELES — The highly infectious BA.2 omicron subvariant is now the dominant version of the coronavirus circulating in the United States, according to federal estimates, a development that is triggering fresh concerns of a potential springtime wave.

The Conversation

How does the COVID-19 prevention drug Evusheld work and who should receive it? An infectious disease specialist explains

The U.S. Food and Drug Administration granted emergency use authorization to AstraZeneca’s COVID-19 antibody drug Evusheld on Dec. 8, 2021. Infectious disease physician Patrick Jackson of the University of Virginia explains how it works, who’s eligible and why some patients are having difficulties accessing it.

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